Symbicort Turbuhaler Dosage/Direction for Use

80 mcg/4.5 mcg: The dosage of Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) should be individualised according to disease severity.
When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
For Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) there are two alternative therapies: Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) maintenance and reliever therapy (SMART): Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) is taken as both regular maintenance treatment, and also as needed in response to symptoms. The as needed inhalations provide both rapid relief and improved asthma control. Patients should be advised to have Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) available for rescue use at all times. A separate inhaler for rescue use is not necessary.
Clinical studies have demonstrated that Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) maintenance and reliever therapy provides clinically meaningful reductions in severe exacerbations while maintaining symptom control, compared to Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) maintenance therapy with a separate rapid-acting bronchodilator (see Pharmacology: Pharmacodynamics under Actions).
Recommended doses: Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
Children (4 years and older): The usual maintenance dose is 1 inhalation once daily. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 4 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations for adults and adolescents and 4 inhalations for children is normally not needed, however a total daily dose of up to 12 inhalations for adults and adolescents and 8 inhalations for children can be used temporarily. If the patient experiences deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) maintenance therapy: Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) taken as regular maintenance treatment, with a separate rapid-acting bronchodilator as rescue. Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Adults (18 years and older): 1-2 inhalations once or twice daily. In some cases, up to a maximum of 4 inhalations twice daily may be required as maintenance dose or temporarily during worsening of asthma.
Adolescents (12-17 years): 1-2 inhalations once or twice daily. During worsening of asthma, the dose may temporarily be increased to a maximum of 4 inhalations twice daily.
Children (4 years and older): 1-2 inhalations twice daily. Maximum daily dose: 4 inhalations.
Increasing use of a separate rapid acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
General information: The patient should be instructed to take the maintenance dose of Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) even when asymptomatic for optimal benefit.
There are no special dosing requirements for elderly patients.
There are no data available for use of Budesonide + Formoterol fumarate dihydrate (SYMBICORT) in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver diseases.
Instructions for correct use of Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER): Turbuhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient: To carefully read the instructions for use in the patient information leaflet which is packed together with each inhaler.
To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
Never to breathe out through the mouthpiece.
To replace the cover of the Budesonide + Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) after use.
To rinse the mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using Turbuhaler due to the small amount of drug dispensed.
160 mcg/4.5 mcg: The dosage of Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) should be individualised according to disease severity.
Asthma: Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) can be used according to different treatment approaches: A. Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever therapy.
B. Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever plus maintenance therapy.
As an alternative, Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) can be used in a fixed dose therapy: C. Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) maintenance therapy.
A. Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever therapy (patients with mild disease): Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) is taken as needed for the relief of asthma symptoms when they occur, and to prevent allergen- or exercise-induced bronchoconstriction (or to prevent symptoms in those circumstances recognised by the patient to precipitate an asthma attack). The formoterol component in Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) provides fast onset of effect (within 1-3 minutes) with long-acting (at least 12 hours after a single dose) bronchodilation in reversible airways obstruction. Patients should be advised to always have Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) available for relief of symptoms.
Clinical studies have demonstrated that Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever therapy provides significant reductions in severe exacerbations and was statistically superior on daily asthma symptom control compared to a short-acting β₂ agonist therapy alone (see Pharmacology: Pharmacodynamics under Actions).
Recommended doses: Physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency.
Adults and adolescents (12 years and older): Patients should take 1 inhalation as needed in response to symptoms and for the prevention of allergen- or exercise-induced bronchoconstriction to control asthma. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. Patients using more than 8 inhalations daily should be reassessed for alternative explanations of persisting symptoms.
Children (4 years and older): Efficacy and safety of Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever therapy in children 4-11 years have not been studied.
B. Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever plus maintenance therapy: When maintenance treatment with a combination of inhaled corticosteroid and long-acting β₂ agonist is required, Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) is taken as anti-inflammatory reliever therapy and in addition, patients take a daily maintenance dose of Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER). The as needed inhalations provide both rapid relief of symptoms and improved overall asthma control. Patients should be advised to have Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) available for relief of symptoms at all times. A separate inhaler for relief of symptoms is not necessary.
Clinical studies have demonstrated that Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) anti-inflammatory reliever plus maintenance therapy provides clinically meaningful reductions in severe exacerbations while maintaining symptom control, compared to Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) maintenance therapy with a separate short-acting bronchodilator (see Pharmacology: Pharmacodynamics under Actions).
Recommended doses: Physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency.
Adults and adolescents (12 years and older): Patients should take 1 inhalation as needed in response to symptoms and for the prevention of allergen- or exercise-induced bronchoconstriction to control asthma. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. Patients also take the recommended maintenance dose, which is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or the evening. For some patients, a maintenance dose of 2 inhalations twice daily may be appropriate.
A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. If the patient experiences deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
Children (4 years and older): A lower strength is available for children 4-11 years.
C. Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) maintenance therapy (fixed dose): When maintenance treatment with a combination of inhaled corticosteroid and long-acting β₂ agonist is required, Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator for relief of symptoms. Patients should be advised to have their separate short-acting bronchodilator available for relief of symptoms at all times.
Recommended doses: Adults (18 years and older): 1-2 inhalations twice daily. In some cases, up to a maximum of 4 inhalations twice daily may be required as maintenance dose or temporarily during worsening of asthma.
Adolescents (12-17 years): 1-2 inhalations twice daily. During worsening of asthma, the dose may temporarily be increased to a maximum of 4 inhalations twice daily.
Children (4 years and older): 1 inhalation twice daily. Maximum daily dose: 2 inhalations. When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
COPD: Adults (18 years and older): 2 inhalations twice daily. Maximum daily dose: 4 inhalations.
General information: If patients take Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) as a maintenance therapy, they should be instructed to take the maintenance dose of Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) even when asymptomatic for optimal benefit.
There are no special dosing requirements for elderly patients.
There are no data available for use of Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver diseases.
Instructions for correct use of Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER): Turbuhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient: To carefully read the instructions for use in the patient information leaflet which is packed together with each inhaler.
To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
Never to breathe out through the mouthpiece.
To replace the cover of the Budesonide + Formoterol fumarate (SYMBICORT TURBUHALER) after use.
To rinse the mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using Budesonide + Formoterol fumarate (SYMBICORT Turbuhaler) due to the small amount of drug dispensed.
320 mcg/9 mcg: The dosage of Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) should be individualised according to disease severity.
When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Budesonide/Formoterol Fumarate Dihydrate (SYMBICORT TURBUHALER) Maintenance Therapy: Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) taken as regular maintenance treatment, with a separate rapid-acting bronchodilator as rescue. Patients should be adviced to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses: Asthma: Adults (18 years and older): 1 inhalation once or twice daily. In some cases, up to a maximum of 2 inhalations twice daily may be required as maintenance dose or temporarily during worsening of asthma.
Adolescents (12-17 years): 1 inhalation once or twice daily. During worsening of asthma, the dose may temporarily be increased to a maximum of 2 inhalations twice daily.
Children (4 years and older): Efficacy and safety have not been studied in children for Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) 320/9 micrograms/inhalation.
Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) 320/9 micrograms/inhalation should be used as Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) maintenance therapy only. Lower strengths are available for the Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) maintenance and reliever therapy regimen.
COPD: Adult (18 years and older): 1 inhalation twice daily.
Maximum daily dose: 2 inhalations.
General information: The patient should be instructed to take the maintenance dose of Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) even when asymptomatic for optimal benefit.
There are no special dosing requirements for elderly patients.
There are no data available for use of Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver diseases.
Instructions for correct use of Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER): Turbuhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient: To carefully read the instructions for use in the patient information leaflet which is packed together with each inhaler.
To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
Never to breathe out through the mouthpiece.
To replace the cover of the Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) after use.
To rinse the mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using Budesonide/Formoterol fumarate dihydrate (SYMBICORT TURBUHALER) due to the small amount of drug dispensed.